Adverse Effects

The most common reported adverse effect of fondaparinux is bleeding. In the large, prospective efficacy studies in VTE, the incidence of major bleeding among patients treated with (therapeutic-dose) fondaparinux was approximately 1% (Buller et al., 2003, 2004). In a registration study of patients undergoing elective total knee replacement, a statistically significant increase in bleeding, as defined by the bleeding index, was noted with fondaparinux, compared to enoxaparin, with no increase in fatal or clinically relevant bleeding (Bauer et al., 2001). A meta-analysis of the phase III registration program studies identified a modest increase in major bleeding (compared with enoxaparin) but without an increase in bleeding leading to death, requiring surgical intervention or bleeding in a critical site (Turpie et al., 2002a). Caution should be used in patients with cutaneous hypersensitivity to UFH, as the literature presents conflicting information regarding the tolerability of fondaparinux in this setting (Hirsch et al., 2004; Jappe et al., 2004; Utikal et al., 2005).

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